Mako® Partial Knee arthroplasty:

clinical summary

Mako clinical evidence

Volume 7
Mako Partial Knee arthroplasty: clinical summary
1. Introduction
Partial knee arthroplasty (PKA), also termed
unicompartmental knee arthroplasty (UKA) when
associated with a single compartment, has been
performed for isolated single compartment knee
osteoarthritis (OA) since the 1970s.1 PKA can be carried
out in the medial, lateral and/or patellofemoral (PF)
compartments.
When compared to total knee arthroplasty (TKA), studies
have shown that medial PKA patients experience greater
retention of normal knee kinematics and accelerated
recovery, while suffering less blood loss and reduced
postoperative morbidity.2-5 Lateral PKA is less common,
comprising around one-eighth of all PKA cases.6
However, lateral PKA has also been shown to be an
effective treatment in the appropriate patient, with
survivorship and outcomes comparable to medial PKA.6-8
PF arthroplasty has also demonstrated significant
benefits to the patient when compared to TKA. A 2018
double-blinded study showed that patients who
underwent PF arthroplasty for isolated PF arthritis had
a better overall knee-specific quality of life than
patients who underwent TKA throughout the first two
years after the operation.9
Despite the volume of evidence demonstrating the
benefits of PKA, the procedure is known to be sensitive
to surgical factors such as implant positioning and soft
tissue balance.10 This was recently highlighted in a study
by Kazarian et al.,11 where data from 253 medial PKA
patients was retrospectively analyzed to assess the
implant survival and radiographic outcomes after PKA,
as well as the impact of component alignment and
overhang on implant survival. All procedures in the
study were performed by two high-volume surgeons.
The results showed that the incidence of PKA revisions
and alignment outliers were greater than expected, even
among high-volume arthroplasty surgeons performing
an average of 14.2 PKAs per year. Both alignment and
overhang outliers were significant risk factors for
implant failure.11 The researchers emphasize that the
ability of low-volume PKA surgeons to consistently
Percentage of knees
attain accuracy in implant position is an important
factor to investigate to help enhance PKA survivorship.11
The Mako System was introduced to provide accurate
implant alignment and anatomic restoration and soft-
tissue balancing, thereby helping the surgeon restore
native knee kinematics and enhance patient outcomes.12-14
This document summarizes the evidence to date that
supports the use of Mako Robotic-Arm Assisted Surgery
for PKA (Mako Partial Knee).
2
2. What evidence is available on
Mako Partial Knee?
Successful clinical outcomes following joint replacement
are dependent on component placement and on restoring
the natural kinematics of the knee. Component malalign­ment
in UKA has been associated with stress concentrations,
bone fracture and poor clinical outcomes.15,16 The Mako
System is designed to minimize the margin of error
associated with component placement and to enhance the
accuracy and reproducibility of PKA. Additionally, the Mako
System helps enable the surgeon to dynamically balance soft
tissue tensioning intraoperatively, with the goal of recreating
natural knee kinematics. Clinical studies have shown that
Mako Partial Knee has the potential to produce accurate
and reproducible component placement in accordance with
preoperative plans17 and to reestablish soft tissue balance.18
2.1 Component placement accuracy
A key clinical paper on Mako accuracy, published by Bell et
al., reports on a randomized controlled trial (RCT) involving
120 patients. The study compared patients who received
robotic-arm assisted PKA (Restoris MCK n=62) with those
who underwent manually implanted PKA (Oxford n=58).17
Comparisons were made between groups in terms of the
preoperative plan of femoral and tibial component positioning
against the actual alignment achieved in three different planes
(axial, coronal and sagittal). Results showed more accurate
component positioning in the robotic-arm assisted group, with
lower root mean square (RMS) errors and significantly lower
median errors in all six component parameters (p<0.01).17
The proportion of patients with tibial slope within 2° of the
target position was significantly greater using the robotic-arm
assisted technique than the manual technique (80% compared
with 22%, p=0.0001). It was concluded that the Mako System
more consistently placed the PKA implant in accordance with
the preoperative plan (Figure 1).17
Percentage of knees with components positioned
within 2° of the target value
80% Mako Partial Knee
70% Manual partial knee
60%
50%
40%
30%
20%
10%
0%
FS FC FA TS TC* TA
Measurement
Figure 1. Bell et al. (2016) showed that use of robotic-arm
assisted PKA enabled surgeons to place the tibial and femoral
components more accurately and consistently to plan.
FS= Femoral Sagittal, FC=Femoral Coronal, FA= Femoral Axial,
TS= Tibial Sagittal, TC*= Tibial Coronal, TA=Tibial Axial.
* = non-significant parameter.17

These results were corroborated by a 2018 study performed
at University College Hospital in London, England,
by Kayani et al.19 A single surgeon compared implant
placement accuracy using radiographs from 60 consecutive
conventional PKAs (Oxford) compared to the surgeon’s
first 60 consecutive Mako Partial Knees (Restoris MCK).
The Mako group had significantly (p<0.001) more accurate
placement to plan for the femoral and tibial implants, as
well as more accurate recreation of the knee’s mechanical
alignment, posterior tibial slope and joint line height.19
A study was performed at Washington University School
of Medicine, U.S., by Kazarian et al. where postoperative
radiological outcomes from 86 consecutive robotic-assisted
UKAs were retrospectively reviewed and compared to
253 manual UKAs drawn from a prior study at the same
institute.20 For the robotic-assisted group, 91.6% of all
alignment measurements and 99.2% of all overhang
measurements were within the target range. All alignment
and overhang targets were simultaneously met in 68.6% of
RAUKAs. When comparing radiological outcomes between
the RAUKA and MUKA groups, statistically significant
differences were identified for rates of outliers in femoral
coronal angle (2.3% vs. 12.6%; p = 0.006), femoral sagittal
angle (17.4% vs. 50.2%; p < 0.001), tibial coronal angle (5.8%
vs. 41.5%; p < 0.001), and tibial sagittal angle (8.1% vs.
18.6%; p = 0.023), as well as anterior (0.0% vs. 4.7%;
p = 0.042), posterior (1.2% vs. 13.4%; p = 0.001), and medial
(1.2% vs. 14.2%; p < 0.001) overhang outliers.20
Matassi et al. considered the likelihood of robotic-assisted
surgery in reducing the variability of coronal and sagittal
component positioning between high- and low-volume
surgeons.21 A prospective cohort of 161 robotic-arm assisted
medial UKA patients were divided into two groups: patients
operated on by “high-volume” or “low-volume” surgeons.
They recorded intraoperative lower-limb alignment,
component positioning, and surgical timing. Postoperatively,
they assessed coronal and sagittal femoral/tibial component
alignment, ROM and patient reported outcomes out to
1-year follow-up. Of the recruited knees, 149 (“high-volume”:
101; “low-volume”: 48) met inclusion. No clinical difference
in mechanical alignment nor coronal/sagittal component
Tourniquet time (min)
positioning were found (p > 0.05) between groups. A
significant difference was recorded in surgical timing
(“high volume”: 57 minutes; “low-volume”: 86 minutes;
p < 0.05). No superficial or deep infections or other major
complications were developed during the follow-up. This
study confirmed the use of robotic-arm assisted technology
for UKA is valuable because it improves the reproducibility
of such a technical procedure as well as provides satisfactory
clinical outcomes. Moreover, it almost eliminates any
possible differences in component positioning, and lower
limb alignment among low-and high-volume knee surgeons.21
Mako Partial Knee arthroplasty: clinical summary
2.2 Surgical team learning curve
During this initial set of 60 Mako Partial Knee cases within
the Kayani et al. study, the surgeon also noted a learning
curve of six cases for operating time and surgical team
confidence levels to become consistent with conventional
PKA statistics.19 The learning curve did not influence any
of the associated accuracy variables, and accuracy to plan
achieved with the Mako System was consistent between
the surgeon’s first Mako case and last 10 Mako cases. This
indicated that Mako Partial Knee surgery did not have
a learning curve for accuracy in achieving the planned
femoral and tibial implant position. Further, no additional
risk was observed for postoperative complications during
the surgical team learning curve.19
Jinnah et al. have previously performed an extensive
multicenter study to understand how learning curve may
influence surgical time for Mako Partial Knee.22 Eight
hundred and ninety-two patients had a Mako Partial
Knee performed by 13 different surgeons. Surgical time
was measured from insertion of the first bone pin to the
acceptance of the final trial components. The average
surgical time for all surgeons was 56 ± 20 minutes. The
shortest average surgical time for an individual surgeon
was 38 ± 9 minutes and the longest was 70 ± 29 minutes.
An average learning curve of 13 cases was proposed for the
surgical time to reach a steady state (Figure 2).22
2.3 Soft tissue balance and bone preservation
From a soft tissue perspective, Plate et al. considered
that the ability to effectively restore a patient’s ligament
length and tension may help with restoration of normal
knee kinematics and muscle lever arms of the knee
joint.18 Their study examined the accuracy of dynamic,
Learning curve
140
120
100
80
60
40
20
0
0 10 20 30 40 50
Number of cases
Figure 2. Typical Mako Partial Knee learning curve graph
showing one surgeon’s first 50 cases from a multicenter study
by Jinnah et al. (2010). After approximately 13 cases, surgical
time reached a steady state.20
3
Mako Partial Knee arthroplasty: clinical summary

real-time ligament balancing for 52 Mako Partial Knees. 3. What are the potential clinical benefits
Gap distances at 0°, 30°, 60°, 90° and 110° flexion were
of Mako Partial Knee?
assessed preoperatively and after final component
implantation to establish whether ligament balancing Mako Partial Knee has been shown to deliver demonstrable
was restored. Ligament balancing was accurate up to clinical benefits.12-14,25-33 Studies have investigated implant
0.53 mm compared to the preoperative plan.18 These survivorship, patient satisfaction, clinical outcomes
results indicated the Mako System was capable of and functional outcomes in medial Mako Partial Knee,
accurately and precisely reproducing the desired soft with favorable results in comparison to other surgical
tissue balance. methods.12-14,25-35 In lateral and PF Mako Partial Knee,
promising clinical and functional outcomes have also been
In addition to this, a cadaveric investigation was carried
observed.35-38 Furthermore, in both medial and lateral PKA,
out with the aim of quantifying the amount of bone
congruence of the nonsurgical and surgical compartments
preserved in robotic medial PKA compared to robotic
has been found to be restored, supporting the hypothesis
TKA.23 Eleven knees were selected and analyzed from
that the resultant redistribution of contact forces across the
seven cadavers. Results showed that robotic PKA
patellofemoral joint could help address PF symptoms.35-38
procedures resected an average of 11.6±1.33 cm3 (range:
9.85-13.7 cm3) whereas total knee procedures resected
an average of 59.7±9.65 cm3 (range: 47.4-78.3 cm3),
3.1 Survivorship
demonstrating that for this study population, only 17% Favorable survivorship data was shared by Vakharia
to 19% of the bone volume was resected in robotic PKA et al. at the American Association of Hip and Knee
compared to robotic TKA. The study highlighted that in Surgeons 2020 annual meeting.39 Their site performed a
robotic PKA, the femur preparation is contoured to match retrospective review of prospectively collected data in
the implant, which may in turn contribute to enhanced their institution’s registry on patients who underwent
bone preservation and retention of bone stock.23 robotic-arm assisted medial UKA. The final query
consisted of 185 patients. Patients had a mean age of 64.9
In another cadaveric study by Hampp et al., they compared
years and mean body mass index (BMI) of 31.6kg/m2 with a
the extent of soft-tissue trauma sustained through robotic-
mean follow-up of 9.98 years. Ten-year survivorship of the
arm assisted PKA and manual PKA.24 Five surgeons,
study cohort demonstrated 98% survivorship and majority
experienced with robotic-arm assisted PKA and manual
of the patients stated they were either “very satisfied”
partial knee techniques, were asked to prepare a total of 24
(80.95%) or “satisfied” (16.19%) with the outcomes of their
cadaveric knees. Afterwards two independent surgeons were
procedure. Furthermore, two patients were revised during
asked to estimate trauma to the patellar tendon, quadriceps
the study period. This study was the first to longitudinally
tendon, anterior cruciate ligament (ACL), medial collateral
follow a large cohort of patients undergoing robotic-arm
ligament (MCL), medial capsule, posterior capsule, and
assisted medial UKA and report on long-term survivorship
posterior cruciate ligament (PCLs) using a five-grade system
and patient-satisfaction.39
where Grade 1 represented complete tissue preservation
and Grade 5 represented over 76% tissue trauma. When In a U.S. study published by Burger et al.31 they evaluated
compared to the manual PKA group, robotic-arm assisted midterm implant survivorship for robotic-arm assisted
PKA had lower total trauma grading (p<0.01), lower PKA patients.31 The research involved a retrospective
posterior capsular damage (p<0.01), and less severe ACL review of patients who underwent robotic-arm assisted
damage (p<0.01). The authors concluded that based on this PKA between 2007 and 2016. Study participants received
analysis the use of robotic-arm assisted devices for PKA can a fixed-bearing medial or lateral PKA, patellofemoral
result in significantly less soft tissue trauma compared to arthroplasty (PFA), or bicompartmental knee arthroplasty
manual PKA.24 (involving a PFA plus medial PKA), and the mean follow-
up was 4.7 years (2.0 to 10.8).31 The five-year survivorship
2.4 Summary of evidence rate of medial PKA (n=802), lateral PKA (n=171) and PFA/
bicompartmental knee arthroplasty (n=35/10) was 97.8%,
These studies demonstrated that robotic-arm assisted
97.7% and 93.3%, respectively.31
technology equipped the surgeon to accurately
and consistently place the femoral and tibial PKA
components17 in accordance with preoperative plans, to
reduce soft tissue trauma,24 and to effectively restore soft
tissue balancing.18 This technology is associated with a
short learning curve to achieve time neutrality compared
to manual surgery, without influencing the ability to
achieve high accuracy.19

4
 Mako Partial Knee arthroplasty: clinical summary

Comparable data was previously confirmed in a multicenter
longitudinal study evaluating short- and midterm
survivorship of robotic-arm assisted medial PKA, which
demonstrated 98.8% survivorship (in 909 knees) at 2.5-year
follow-up and 97% survivorship (in 432 knees) at 5.5-year
follow-up.12,20 This survivorship rate was greater than rates
derived from high-volume surgeon data and registry data
for conventional PKA (Figure 3).12,20 The study concluded
that the favorable survivorship observed resulted from
Mako’s ability to help enable surgeons to achieve more
accurate component positioning when compared to implant
placement using manual techniques.12,20
An RCT by Gilmour et al., comparing patients who
underwent medial Mako Partial Knee (Restoris
MCK) with those who underwent manual medial
PKA (Oxford) demonstrated encouraging results.
Specifically, Mako Partial Knee patients had 100%
survivorship compared to 96.3% in the manual group
Partial knee survivorship
100%
99%
98%
97%
Percentage
Cohort studies
Annual registries
Mako Partial Knee
at two years postoperation.41 The 100% survivorship
rate was maintained in the robotic group at five years
postoperation.42
Similar promising data was published in the 2021
Australian Joint Registry,25 which reported the
cumulative percent revision for Restoris MCK medial
PKA as 1.5% at one year, 3.2% at three years and 4.2% at
five years. These rates were lower when compared to all
cases performed without robotic assistance, which were
reported to be 2.0%, 4.2% and 5.6% at one, three, and
five years, respectively. Furthermore, the cumulative
revision rate of the Restoris MCK medial PKA also
compared favorably to the revision rate for all Oxford
medial PKA replacements, which were 2.2% at one year,
5.7% at three years, and 8.2% at five years.25 These
findings were reflected in a study conducted by St Mart
et al.,34 who examined the cumulative revision rate of
PKA procedures implanted with the Mako System using
data from the Australian Joint Registry between 2015
and 2018. The researchers found that the Mako-assisted
Restoris had significantly lower overall revision rate
compared to other types of non-robotically assisted PKA
procedures. However, the higher rate of early revision
for infection for robotically assisted PKA requires

96%
further investigation.34
95%
94% The revision rates for Mako Partial Knee have been
93% published in cohort studies, economic analyses, level
92% I clinical trials (RCTs) and international registries
91% (Figure 4). The evidence supports excellent survivorship
90% of the Restoris MCK implant.
2-3 year follow-up 5-6 year follow-up
Figure 3. Survivorship data from Pearle et al. (2017)22 and
Kleeblad et al. (2018)12 on robotic-arm assisted PKA compared to
studies in literature and annual registries reporting 2 to 3 years
and 5 to 6 years conventional PKA survivorship data.

Survivorship
Multiple studies demonstrate a low revision rate for Mako Partial Knee

AAONJR 2021, n=5162

4
4.2

Kleeblad et al., n=384

3 St Mart et al., n=2851 3
Revision rate %

Burger et al.,
2.6 n= 802
2.2 2.2
2
Zambianchi et al., n=224
2
Vakharia et al., n=185
1.2 Pearl et al., n=909 1.2 Deese et al., n=51 Registry
1
0.81 Cohort
Cool et al., n=51 Dretakis et al., n=51 Banger et al., n=65 Economic
0
0 0 RCT
0 20 40 60 80 100 120 140

Months follow-up
-1

Figure 4. Graph indicating Mako Partial Knee revision rates with data taken from cohort studies, economic analyses, level I clinical
trials (RCTs) and international registries.12, 20, 25, 31, 34, 39, 42-46

5
 Mako Partial Knee arthroplasty: clinical summary
3.2 Patient satisfaction
In a multicenter longitudinal clinical trial, the vast majority
of Mako Partial Knee patients were “very satisfied” or
“satisfied” with their joint replacement.12,40 This study
performed follow-up at 2.5 years (909 knees) and 5.5 years
(432 knees) with patients who underwent medial Mako
Partial Knee procedures.12,40 92% of patients reported
satisfaction with their knee 2.5 years postoperatively
and 91% of patients reported satisfaction at 5.5 years
(Figure 5).12,40 In a similar study based on the Swedish
Knee Arthroplasty Registry, 83% of 7,860 patients who
underwent manual medial PKA were satisfied with their
knee at an average six-year follow-up.26
Using the Mako System, Coon et al. performed 152 (71.3%)
medial PKAs, 33 (15.5%) lateral PKAs, 20 (9.4%) medial
bicompartmental PKAs and 8 (3.8%) patellofemoral PKAs.
All surgical procedures had high patient satisfaction with
an average of 82.5% of patients reporting being very
satisfied or satisfied at six months, which increased to
89.5% at two years.29 The lateral PKA group reported 100%
satisfaction two years postoperation.30
Comparable midterm patient satisfaction data was recently
published in a large single-surgeon study of 1018 knees,
where a large proportion of patients who underwent
robotic-assisted PKA reported high satisfaction levels.31 The
mean follow-up was 4.7 years (2.0 to 8.0), and the results
showed that 90.7% of medial PKA patients, 92.6% of lateral
PKA patients and 78.9% of PFA or bicompartmental knee
arthroplasty patients were either very satisfied or satisfied
with their knee function.31
Mako Partial Knee patient satisfaction
80%
Minimum 2-year follow-up
70% Minimum 5-year follow-up
60%
Percentage
50%
40%
30%
20%
10%
0%
Very Satisfied Neutral Dissatisfied
satisfied
Figure 5. Midterm patient satisfaction with medial Mako Partial
Knee procedures (Kleeblad et al., 201812 and Pearle et al., 2017 22).
6
3.3 Clinical outcomes
An RCT performed by Blyth et al. found that patients
who underwent medial Mako Partial Knee experienced
less pain than those who underwent manual surgery
during the 90-day postoperative period.13 Median pain
scores were 55.4% lower in robotic-arm assisted patients
compared to manual patients from day one to day 56
(Figure 6).13 Furthermore, the robotic-arm assisted patients
had a better American Knee Society Score (AKSS) at three
months postoperatively and at one year postoperatively,
and a greater proportion of robotic-arm assisted patients
showed improvements in their UCLA Activity Score.13
Through binary logistic regression, the study was also
able to predict the key factors associated with achieving
excellent outcomes on the AKSS. These factors were a
preoperative UCLA Activity Score level >5 and the use
of robotic-arm assisted surgery, although these do not
withstand adjustment for multiple comparisons.13
Partial knee pain scores
70
Robotic assisted
Median pain VAS score 0-100
Manual surgery
60
50
40
30
20
10
0
0 1 2 3 4 5 6 7 14 21 28 35 42 49 56 63 70 77 84 91
Days postoperative
Figure 6. Visual analog pain score collected up to 90 days
postoperatively in a RCT of manual vs. robotic arm-assisted
medial PKA procedures.13
Very
dissatisfied
 Mako Partial Knee arthroplasty: clinical summary

In two separate studies, evidence showed that medial Furthermore, the same powered (1:3 ratio) cohort
Mako Partial Knee patients were more likely to “forget” study by Clement et al. published encouraging early
their artificial joint during daily life compared to postoperative outcomes data, where statistically and
those who underwent manual TKA.27,28 Zuiderbaan clinically significant greater knee-specific functional
et al. administered The Forgotten Joint Score (FJS) outcomes were observed in robotic PKA patients
questionnaire one and two years postoperatively.27 Scores compared to those who underwent manual TKA.28
were compared between 65 patients who underwent Findings showed that the robotic PKA group had a
medial Mako Partial Knee and 65 patients who underwent significantly greater six-month Oxford Knee Score
manually instrumented TKA.27 Results demonstrated by nearly eight points, and there was a five-point
patients who underwent medial robotic-arm assisted PKA (95% confidence interval 1.9 to 8.1; p < 0.001) greater
were more likely to forget their artificial joint in daily life improvement in the robotic PKA group compared to
(Figure 7).27 Similarly, in a separate powered cohort study the manual TKA group, which was greater than the
from the U.K., conducted by Clement et al.28, 30 patients minimal clinically important difference. This positive
who underwent Mako PKA were propensity score matched early outcome data was further fortified within the
to 90 patients who underwent manual TKA for isolated study as the researchers also found that the robotic PKA
medial compartment arthritis. The findings from this group had significantly better postoperative pain visual
study showed that the six-month FJS was significantly analog scale (VAS) scores compared with the manual
greater for the robotic PKA group compared to the manual TKA group (Table 1).28
TKA group (difference 24.2, p < 0.001) (Figure 7).28
Table 1. Six-month postoperative outcome measures and
differences between robotic PKA vs. manual TKA.27
Forgotten joint score
Medial UKA
80 Mean Difference
TKA rUKA mTKA p-value*
PROM (SD) (95% CI)
70 Postoperative 44.2 (4.4) 7.7
36.5 (9.4) <0.001
OKS (4.2 to 11.3)
60
Postoperative 77.1 (25.9) 24.2
50 52.9 (32.6) <0.001
FJS (11.2 to 37.2)
40 Postoperative 0.913 (0.126) 0.764 (0.248) 0.148
EQ-5D (0.054 to 0.241) 0.002
30
Postoperative 93.6 (12.3) 20.5
76.4 (24.8) <0.001
20 pain VAS (9.9 to 31.0)
* Unpaired t-test.
10 CI, confidence interval; EQ-5D, EuroQol five-dimension questionnaire; FJS,
Forgotten Joint Score; mTKA, manual total knee arthroplasty; OKS, Oxford
0 Knee Score; PROM, patient-reported outcome measure; rUKA, robotic
Six months One year Two years unicompartmental knee arthroplasty; VAS, visual analog scale.
Figure 7. FJS at six months, one and two years post-operation
Overall, results of these studies suggested positive
showing significantly higher scores in the medial Mako Partial
Knee group (p<0.001, p=0.002 and p=0.004, respectively) 26,27 clinical and patient-reported outcomes of robotic-arm
assisted medial, lateral, PF and bicompartmental
PKA.10, 12-14, 22, 28-31, 34, 41

7
 Mako Partial Knee arthroplasty: clinical summary
3.4 Functional outcomes
Gait analysis has been used to compare outcomes of
robotic-arm assisted PKA patients to those of manual
Oxford PKA patients. In an RCT, Motesharei et al.
compared the gait of 31 robotic PKA patients to 39 Oxford
PKA patients one year postoperatively.32 Both groups were
compared to a control group of 50 healthy subjects obtained
from the University of Strathclyde’s archive.32 Results from
this study showed statistically significant differences in
knee joint kinematics during level walking between the
robotic-arm assisted and manual PKA groups. The robotic-
arm assisted group achieved a higher knee excursion (18.0°,
SD 4.9°) compared to the manual group (15.7°, SD 4.1°)
(Figure 8 and Table 2).32 There was no significant difference
between the healthy group and the robotic-arm assisted
group, but there was a significant difference between the
healthy group and the manual group (p<0.001).32
This study was repeated at five-years postoperatively
by Millar et al., though on fewer patients (25 Mako vs.
21 Oxford), and the differences seen at one year were
maintained.14 Results showed that the Mako group
achieved significantly greater knee flexion in weight
acceptance than the conventional group (Table 3).14 These
findings suggested that the improved alignment offered
by the Mako System may result in enhanced function of
the knee during gait, and that the use of the Mako System
resulted in a gait pattern that facilitated the normal
Partial knee gait
60
Knee excursion angle (degrees)
Control
Robotic-arm assisted
50
Manual
40
30
20
10
0 Patient group
0 20 40
Percentage of gait (%)
Figure 8. Mean knee excursion angles of the control group, the
robotic-arm assisted and manual PKA groups during the stance
phase of gait at one year post-operation.31
8
function of the knee more closely than the conventional
technique.14,32
A clinical study by Borus et al. assessed functional
performance in patients who received robotic-arm assisted
PKA compared to those who received manual TKA.33 Tests
included a six-minute walk, timed up and go, and stair
ascend/descend, which were measured preoperatively
and at six weeks and at three months postoperatively.
Although a statistically significant difference in functional
performance change between groups was not reached, the
authors highlighted that at six weeks, the robotic PKA group
was able to walk an additional 21.00 meters (68.90 feet)
compared to just 5.95 meters (19.52 feet) for the manual
TKA group.33 Very similar functional differences were
observed with the timed up and go and stair ascend/descend
tests, suggesting that robotic PKA provided functional
benefits that were at least equivalent to manual TKA.33
Research by Coon et al. on medial Mako Partial
Knees, lateral PKAs, medial bicompartmental PKAs
and patellofemoral PKAs showed that at two years
postoperatively, 87.9% of patients were as active or the
same as they expected they would be before surgery.30 In
addition, the average distance walked at discharge was
79.8 meters, and 90.9% of patients were walking without
support three weeks postoperatively.30 Lastly, 65 patients
were employed at time of surgery, and 86% of those
patients returned to work six weeks after their operation.30
Table 2. Comparison of knee excursion values during loading
phase of gait at one year post-operation. Standard deviation in
brackets.31
Control Mako Oxford
Knee excursion from 19.5 (4.0) 18.0 (4.9) 15.7 (4.1)*
foot-strike to mid-
*Significantly different than the
stance (degrees)
control group
Table 3. Mean (SD) excursion during weight acceptance for each
patient group at five years post-operation.14
Mean (SD) excursion during WA (°)
60 Mako 14.3 (6.4)
Oxford 9.9 (4.2)
P 0.008
 Mako Partial Knee arthroplasty: clinical summary

Table 4. Mean (±SD) scores of WOMAC and FJS of all patients undergoing medial and lateral UKA and stratified by postoperative
alignment as neutral or undercorrected.33

Postoperative alignment Score N Medial UKA N Lateral UKA Medial vs. lateral
WOMAC 143 89.8±11.7 36 90.2±12.4 0.855
All patientsa
FJS 95 71.2±24.5 25 70.9±28.2 0.956

WOMAC 85 90.9±11.4 19 87.2±12.5 0.200

Neutral aligned patients (–1° to 3°)
FJS 57 72.6±22.6 12 55.3±28.5 0.024*

WOMAC 51 88.5±11.6 15 96.0±5.4 0.001*

Undercorrected patients (3° to 7°)
FJS 38 68.2±26.8 13 85.3±19.5 0.020*

WOMAC 143 0.214 0.005*

Neutral vs. undercorrected
FJS 143 0.199 0.010*
UKA indicates unicompartmental knee arthroplasty; FU, follow-up; WOMAC, Western Ontario and McMaster Universities Arthritis Index; FJS,
Forgotten Joint Score. Neutral alignment for medial UKA indicates one degree of valgus to three degrees of varus and for lateral UKA indicates
one degree of varus to three degrees of valgus.
Undercorrected alignment for medial UKA indicates three degrees to seven degrees of varus and for lateral UKA indicates three degrees to seven
degrees of valgus.
* Indicates a significant difference with p < 0.05.
a 12 patients with medial UKA and 2 patients with lateral UKA had no postoperative hip-knee-ankle radiograph and could not be included for
subgroup analysis.

3.5 Clinical outcomes of lateral PKA

Lateral PKA is less frequently performed within the
general population, accounting for just one-eighth of
PKA cases.6 However, this procedure has been shown
to be effective for the appropriate patient, achieving
reliable improvements in pain, function and implant
survivorship.6-8 The Mako robotic platform offers
potential benefits through its demonstrated accuracy and
reproducible implant positioning, helping to minimize the
margin of error associated with component placement.12 In
addition, the platform enables intraoperative dynamic soft Figure 9. Preoperative and postoperative radiographs of: medial
tissue balancing to help the surgeon recreate the patient’s Mako Partial Knee (left), and lateral Mako Partial Knee (right).33
natural knee kinematics.
Similar promising survivorship data was published by
Promising results have been reported by several studies
Augart et al.48 The authors performed a search of their
examining lateral Mako Partial Knee.47,48 For example,
institution’s joint registry and found 88 lateral robotic-
a retrospective study conducted by van der List et al.
arm assisted PKA patients, with a mean follow-up of 24.4
compared two-year postoperative functional outcomes
months ±10.7 months, who had 100% survivorship at final
using the Western Ontario and McMaster Universities
follow-up without revision to TKA.48 The promising data
Osteoarthritis Index (WOMAC score) and FJS, between
observed thus far from medial and lateral Mako Partial
143 medial and 36 lateral Mako Partial Knee procedures
Knees suggests that the potential benefits offered by the
(Figure 9, Table 4).47 Equivalent functional outcomes were
Mako robotic platform, with regards to surgical planning,
noted for both medial and lateral PKA procedures.47
precision, reproducibility and intraoperative soft tissue
adjustments, have the potential to help enhance surgical
accuracy during these technically demanding procedures.

9
Mako Partial Knee arthroplasty: clinical summary

3.6 Continuum of care Similarly, in a 2020 study by Burger et al.,49 researchers

As mean patient age decreases, partial knee arthroplasty
is often indicated as a conservative treatment to delay
need for a total knee replacement. Studies of joint line
restoration, patella tracking, and medial and lateral
compartment congruency have been conducted at Hospital
for Special Surgery in New York.35-37 In all three studies,
congruence of the surgical compartment was restored
through the Mako procedure and implant.35-37 Congruence
and joint line of the nonoperative compartment were also
restored (p=0.001).35 The authors hypothesized that the
improved patellofemoral congruence after Mako Partial
Knee may lead to redistribution of contact forces across the
patellofemoral joint and secondarily treat PF symptoms
(Figure 10, Figure 11, Figure 12).35,48
Pre-operative
Original date
25
Tibia
20 Femur
aimed to explore the effect of patellofemoral joint pathology
on lateral PKA. In particular, the effect of preoperative
radiological degenerative changes and alignment on
patient-reported outcome measures (PROMs) after lateral
PKA was evaluated, as well as the influence of lateral
PKA on the alignment of the patellofemoral joint.49 A
consecutive series of 140 knees in 130 patients who
underwent Mako robotic arm-assisted fixed-bearing
lateral PKA were retrospectively reviewed. Radiological
evaluation was conducted to obtain a Kellgren Lawrence
(KL) grade, an Altman score and alignment measurements
for each knee. Postoperative PROMs were assessed using
the Kujala (Anterior Knee Pain Scale) score, Knee Injury
and Osteoarthritis Outcome Score Joint Replacement
(KOOS JR) and satisfaction levels. The results showed that
at mean 4.1 years (2.0 to 8.5) follow-up, good to excellent
Kujala scores were reported, and the presence of mild to
moderate preoperative patellofemoral joint osteoarthritis
had no impact on these scores (KL grade 0 vs. 1 to 3, p =
0.203; grade 0 to 1 vs. 2 to 3, p = 0.674). Comparable scores
were reported by patients with osteoarthritis evident on
either the medial or lateral patellofemoral joint facet, and
patients with abnormal patellar congruence and tilt angles
Post-operative
(≥ 17° and ≥ 14°, respectively) reported good to excellent
Kujala scores. Furthermore, it was evident that lateral PKA
Original date
25
Tibia
20 Femur

15 15 resulted in improvements to patellofemoral alignment.49

10
10 15 20 25
INDX 0.85
30 35 40 45
10
15 20 25 30
INDX 0.96
35 40 45
The findings from this study are encouraging as this
is the first study demonstrating that mild to moderate
21 25
Tibia Tibia
20 Femur Femur

preoperative radiological degenerative changes and

19 20
18

malalignment of the patellofemoral joint are not associated

17 15
15 20 25 30 35 40 45 15 20 25 30 35 40 45

Figure 10. Khamaisy et al. (2016). Iterative closest point with poor patient-reported outcomes at midterm follow-up
algorithm was performed to calculate the congruence index after lateral fixed-bearing PKA. The researchers went on to
(noted as INDX in the figure) of the lateral compartment
pre- and postoperatively following manual digitization of the
suggest that this may be explained by realignment of the
femoral and tibial surfaces in patients who received a medial patella and the resulting redistribution of loads across the
Mako Partial Knee.37 patellofemoral joint.49

Figure 11. Preoperative Merchant view of a left knee. The Figure 12. Postoperative Merchant view of a left knee.
trochlear angle (red angle) is 140°. The congruence angle The trochlear angle (red angle) is 140°. The postoperative
(yellow angle) is 14°. The medial patellofemoral joint space congruence angle (yellow angle: 6°) was decreased compared
is represented by the purple line.36 to the preoperative one (Figure 12). Moreover, the medial
patellofemoral joint space (purple line) was increased by 1.5 mm
following PKA.36

10

3.7 Outcomes of patellofemoral arthroplasty
The purpose of patellofemoral arthroplasty is to address the
pain caused at the patellofemoral joint without performing
a more substantial total knee surgery that would sacrifice
additional bone. However, past literature has reported
conflicting success rates of PFA as a surgical treatment for
patellofemoral OA.50,51 Odgaard et al. used a multicenter,
double-blinded RCT to compare clinical outcomes associated
with PFA and TKA to establish whether there was an
advantage to either option.52 They found that PFA patients
recovered quicker than TKA patients, and the functional
outcomes were also better for PFA patients.52 The average
TKA patient lost almost three months of knee function
postoperatively during the first two years, relative to the
PFA patient.52 It was concluded that PFA was a superior
option to TKA in patients with patellofemoral OA.52
Encouraging functional data was observed in another study
by Noyes et al., which examined the early results of 33
prospective, consecutive third-generation Mako PFA
procedures.38 The authors analyzed both sports and work
activity levels in younger active patients. The study
included 33 consecutive PFAs in 29 patients (four bilateral),
with a mean age 40 (range, 22-68).38 All patients received a
comprehensive clinical evaluation, Cincinnati Knee Rating
and International Knee Documentation Committee (IKDC)
objective rating. They also received radiographic evaluation.
Results showed high levels of participation in light sports:
22% preoperatively, rising to 87% postoperatively. A total of
85% of patients in the employed subgroup returned to work
postoperatively, and in six out of seven patients who
received surgery due to articular cartilage restoration
failure, improvement was seen postoperatively and they
returned to light sports/work.38 This research demonstrated
that robotic-arm assisted PFA was a successful treatment
option in younger active patients with isolated PF arthritis,
enabling the majority of those patients to return to low-
impact recreational activities and occupations.38
Mako Partial Knee arthroplasty: clinical summary
3.8 Outcomes of bicompartmental knee
arthroplasty
Bicompartmental knee arthroplasty (BiKA) may be an
alternative for TKA candidates with localized arthritis.
The advantages of BiKA in comparison to TKA is that it is
more minimally invasive.53 It requires less bone removal
and preserves the anterior and posterior ligaments which
may lead to better stability and proprioception for the
patient.54-56 Studies have reported BiKA resulting in less
scaring, need for less blood transfusions, reduced surgical
morbidity, and faster rehabilitation when compared to
TKA.53 However, there are also concerns around the
complication rates for BiKA with component positioning
listed as possible culprit.15,17
Gaudiani et al. published on their prospectively maintained
cohort of 50 patients (53 knees) who underwent BiKA
(patellofemoral and medial compartment) at five-
and seven-year follow-up.57 The group reported high
survivorship rates, with 96% at five years and 93% at
seven years.57 At a mean follow-up of 7.1 years (range
7.0 – 7.3), 89% of patients reported being either satisfied
or neutral with their BiKA where 11% reported being not
satisfied.57 A mean Knee Society – Function Score of 80.5 ±
15.8 with 82% of patients reporting walking more than 10
blocks, 89% walking without support, and 100% able to go
up and down stairs with 61% requiring use of a hand rail.57
11
Mako Partial Knee arthroplasty: clinical summary

4. Is Mako cost-effective? mPKA. Model inputs included hospital costs, implant

Compared to TKA, studies have shown that UKA
patients have fewer postoperative complications,58
improved FJS,27,28 and higher quality-adjusted life-years
(QALYs) in older patients.45,59,60
With rising demand for PKA in patients who seek
restored function and a quicker recovery time, a U.S.
study performed by Kazarian et al. evaluated the
cost-effectiveness of PKA compared to TKA as well as
nonsurgical treatment (NST).59 Using a Markov decision
analytic model, the authors assessed lifetime costs and
QALYs as function of age at time of initial treatment
(ATIT) of patients with end-stage unicompartmental
knee osteoarthritis. The analysis included direct
medical and indirect costs. Models were run for ATITs
at five-year intervals from 40 through 90 years of
age. Results indicated PKA had the greatest QALY
accumulation followed by TKA and NST, and that PKA
was more cost-effective compared to NST for patients
aged 40 to 86. Furthermore, when surgical treatments
were compared, PKA dominated TKA by generating
more QALYs than TKA for all ATITs. The authors
further concluded that if PKAs were performed as 12%
to 20% of the total volume of knee arthroplasties versus
the less than 8% observed, it would lead to a lifetime
cost-savings of 987 million to 1.5 billion U.S. dollars and
increased lifetime QALY accumulation of 124,403 to
217,705 across the U.S. population.59
survival and mortality rate. Using a model with an
annual case volume of 100 patients, the cost per QALY of
rPKA was £1,395 and £1,170 relative to mTKA and mPKA,
respectively. The cost per QALY was influenced by case
volume: a low-volume center performing 10 cases per
year would achieve a cost per QALY of £7,170 and £8,604
relative to TKA and PKA, respectively. For a high-volume
center performing 200 rPKAs per year with a mean two-
day length of stay, the cost per QALY would be £648;
if performed as day cases, the cost would be reduced
to £364 relative to TKA. For a high-volume center
performing 200 rPKAs per year with a shorter length of
stay of one day relative to PKA, the cost per QALY would
be £574 (Figure 1460). Furthermore, the cost per QALY
of rPKA decreased with reducing length of hospital stay
and with increasing case volume, compared with mTKA
and mPKA.60 The model showed that rPKA was a cost-
effective alternative to mTKA and mPKA for patients
with isolated medial compartment OA of the knee.
In summary, these models demonstrated that in patients
with isolated medial compartment arthritis, PKA was
observed to be a more cost-effective procedure compared
to nonsurgical treatment and TKA for the specified age
groups modelled, thus concluding rPKA was cost-effective
compared to TKA.
A hospital in Brisbane, Australia examined the potential
cost-savings for the health system and the community

In a separate U.K.-based study, a Markov decision

analysis was performed to assess the cost-effectiveness 7500
of robotic PKA (rPKA) relative to manual TKA (mTKA) and
7000 Same
manual PKA (mPKA) for patients with isolated medial Four nights
compartment OA of the knee with a mean age of 65 6500 Three nights
years.60 The study objective was to identify the cost per Two nights
6000
quality adjusted life-year of rPKA relative to mTKA and One night
Day case
5500
$50 5000

PKA vs NST 4500

$40 TKA vs NST
PKA vs TKA 4000
Cost per QALY (£)

$30 3500
ICER (thousands)

3000
$20
2500

$10 2000

1500
$• 1000
40 45 50 55 60 65 70 75 80 85 90
500
-$10
0
20 40 60 80 100 120 140 160 180 200
-$20 Number of patients
ATIT
Figure 14. Cost per quality-adjusted life-year (QALY) or robotic-
Figure 13. ICER values comparing PKA with NST, TKA with NST, and assisted PKA according to case volume and length of hospital
PKA with TKA by age.52 stay relative to TKA.53

12

in a broadly accessible model through the increased
utilization of PKA using robotic-arm assisted PKA vs.
conventional TKA.38 They retrospectively reviewed 240
patients where the first 120 consecutive Mako Partial
Knees performed during this period were matched to
120 conventional TKAs. Clinical data from the medical
records and costs for procedure for each component
were collected. Bivariate analyses were performed on the
data to determine if there were statistically significant
differences by surgery type in clinical outcomes and
financial costs. The study found a significantly lower cost
incurred for robotic-arm assisted PKA vs. TKA with an
average savings of AU$7,179 per case. The operating time
(86.0 min vs. 75.9 min; p=0.004) was significantly higher
for PKA but the length of stay was significantly lower
(1.8 vs. 4.8 days; p<0.001). This study also found a
significant difference in the use of opioids in PKA
compared to TKA (125.0 morphine equivalent (ME) vs.
522.1 ME, p<0.001).38
In the U.S., in a study by Cool et al., reasons for revisions
and associated costs were analyzed for unicompartmental
arthroplasty cases.45 UKA procedures were identified
using a commercial administrative claims database to
evaluate hospital admissions for revision surgeries.
Robotic UKA (rUKA, Mako Partial Knee) and manual
UKA (mUKA, manual partial knee) procedures performed
between March 1, 2013 and July 31, 2015 were used to
calculate the rate of revisions within 24 months of the
index procedure. Cases were propensity matched 2:1
based on age, sex, race, geographic division, high-cost
comorbidities and concentration of healthcare specialists
per 100,000 population to control for outside confounding
factors at case index. A total of 738 commercial health
plan patients (246 rUKA, 492 mUKA) were selected for
inclusion in the analysis. Results indicated fewer revision
procedures in rUKA (0.81% (2/246) vs. 5.28% (26/492);
p=0.0017) and rUKA patients incurred lower mean costs
for the index stay plus revision(s) ($26,001 vs. $27,977;
p>0.05). Lower length of stay at index was also noted in
the rUKA group (1.77 vs. 2.02 days; p=0.0047). The study
concluded that patients who underwent rUKA had fewer
revision procedures, shorter LOS and incurred lower
mean costs at 24 months.45
Mako Partial Knee arthroplasty: clinical summary
Findings from a 2020 U.K. cohort study involving
30 Mako Partial Knees compared to 90 propensity-
matched manual TKAs showed that the length of stay
was significantly (p < 0.001) shorter in the robotic-arm
assisted PKA group (median two days, interquartile range
(IQR) one to three) compared to the manual TKA group
(median four days, IQR three to five). The shorter length
of stay observed in this study was considered a cost
saving for the center relative to mTKA.28
The cost-effectiveness studies described above all
differed in inputs specific to their country, local region,
hospital system or payer. These studies demonstrated
that robotic-arm assisted partial knee arthroplasty, in
comparison to manual TKA or manual partial knees,
was associated with lower costs and/or improvements in
QALY.59-61
5. Conclusion
Mako Partial Knee offers the potential for surgeons to
achieve component placement accuracy,17 soft tissue
balancing18 and reduced soft tissue trauma24 as well
as to enhance clinical outcomes.12-14,25-33,40,41 Patients
have reported tangible benefits of robotic-arm assisted
procedures, including treatment satisfaction,12,27,29,31,40
return to activities of daily living29 and a “forgotten”
joint.13,27,28 Surgeons are empowered to achieve their
target preoperative plans with precision,17 helping
distinguish them within their medical communities.
The cost-effectiveness studies described here
demonstrated favorable economic returns, lower costs
and better improvements in QALY for patients who
received robotic-arm assisted partial knees in contrast
to those received TKA or manual partial knees.59-61
Ultimately, the benefits of Mako Partial Knee surgery
are reported to be experienced by all key players –
patients, surgeons and health systems.
13
Mako Partial Knee arthroplasty: clinical summary
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